As of 1st June 2016, more than 15,000 Baguera C have been successfully implanted worldwide. The first surgery was held in France in January 2007.
According to a company release, the Baguera C’s anatomical shape, shock-absorption, guided mobile nucleus and...

SeaSpine has announced the full commercial launch of its Hollywood VI NanoMetalene transforaminal lumbar interbody fusion device.
Hollywood VI NanoMetalene is indicated for use in spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with...

According to a press release from Mazor Robotics, Ronald Lehman has become the first person in New York City, USA, to perform a PROlat procedure using the Mazor Robotics Renaissance Guidance System.
Lehman used the technology to assist in a...

SpineCraft reports it has completed 15,000 Apex spine system surgeries globally.
The instrumentation system is designed for complex deformity correction as well as tumour, trauma and degenerative procedures.
Anis Mekhail of the University of Illinois Hospital and Parkview Orthopaedic Group says,...

KB Medical has received CE marking certificate for its AQrate robotic assistance system, indicated for precise positioning of surgical instruments and spinal implants during general spinal surgery.
According to a company release, KB Medical has developed a hardware and software...

Spineology has released the Elite expandable interbody fusion system.
The Elite expandable interbody fusion system is designed to be implanted at a minimal height and expanded after final positioning in the disc space. This is intended to enable the surgeon...

Medicare Administrative Contractor (MAC), First Coast Service Options (FCSO), which covers the state of Florida as well as Puerto Rico and the US Virgin Islands, has established coverage criteria for minimally invasive sacroiliac joint fusion. This is the last...

SpineGuard has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new PediGuard Threaded DSG (Dynamic Surgical Guidance) device.
“We are very excited by the clearance of our PediGuard Threaded device, which brings a new generation...

Geisinger Health Plan, a commercial health plan covering more than 500,000 individuals in the US states of Delaware, Maine, New Jersey, Pennsylvania, and West Virginia has issued a revised medical policy for sacroiliac joint fusion that exclusively covers the...

Amedica has submitted its responses to the US Food and Drug Administration (FDA) in relation to the CASCADE clinical trial.
The CASCADE study compared the 24-month outcomes from single-level cervical fusion between Amedica’s porous silicon nitride versus bone autograft. Data...

The US Food and Drug Administration (FDA) has cleared a 510(k) to allow modification of Si-Bone’s indication statement for iFuse, noting that clinical studies have demonstrated treatment with the system can improve pain, patient function and quality of life.
The...

Titan Spine is to provide a free replacement if any of the company’s Endoskeleton interbody fusion devices delaminate or generate particulate debris during implantation, updating the product warranty.
According to a company release, the amended warranty reflects Titan Spine’s confidence...

A new study in zebrafish by researchers at Princeton University and the University of Toronto suggests that irregular fluid flow through the spinal column brought on by gene mutations is linked adolescent idiopathic scoliosis. Also found in people, these...

An international, large-scale multicentre study of 33 spine institutes indicates that facet joint tropism—also known as facet joint angulation asymmetry—may be developmental in origin or may be a combination of developmental aspects and secondary changes of degenerative effects. This...

This drawing depicts plans to recognise the newly named Exactech Arena at the Stephen C O’Connell Center, a sports and entertainment complex at the University of Florida in Gainesville, USA. The remodelled facility is scheduled to re-open in December 2016.
Exactech...

LDR has announced the initial implantations of the ROI-C titanium-coated cervical cage. The first surgeries were performed by Mark Giovanini, a board-certified neurosurgeon specialising in minimally invasive spine surgery in Pensacola, USA, and Neil Romero, a board-certified orthopaedic surgeon...

InVivo Therapeutics has appointed Christina Morrison to its board of directors effective immediately. Most recently, Morrison served as the senior vice president of finance for Aramark. She joined Aramark in June 2013 as senior vice president of finance. Mark...

ChoiceSpine has received 510(k) clearance from the US Food and Drug Administration (FDA) to market titanium lumbar interbody fusion devices.
A ChoiceSpine press release states that the company now plans to offer titanium interbody devices for traditional PLIF (posterior lumbar...

Avitus Orthopaedics has launched pilot sales of its Avitus bone harvester product following the receipt of its 510(k) approval.
The Avitus bone harvester, which has received 510(k) clearance from the US Food and Drug Administration as a class II medical...

CTL Medical has announced the executive management team that will lead the organisation into the next phase of its growth. “We have a solid group of executives that we have brought into management roles,” said Daniel Chon, president and...

Health Outcome, a consumer website focused on bridging the information gap for treatment outcomes, has launched the first crowdsourcing platform for patients to rate their treatment experiences and help others find evidence based cures.
Health Outcome is currently the largest...

New York City’s Hospital for Special Surgery has acquired a third EOS system.
The hospital installed its first EOS in 2013 for paediatric cases and its second EOS in 2015 for adult cases. The third EOS system will be dedicated...

Virginie Lafage entered the world of spinal research by chance, after an engineering project drove her to a biomechanics lab in Paris, France. Since then, she has moved to the USA, become an executive member of the International Spine...

Screw placement accuracy is a critical point in instrumented spinal fusion, especially in difficult deformity cases There is a real, established risk of pedicle screws malposition and related complications, reported in literature at a range of 8–30%, writes Claudio...

Seeking to “go beyond the evidence presented by randomised control trials”, a group of researchers has used the international Spine Tango registry to compare the results of randomised control trials with those of real-world patients treated by either single-level...

NuVasive has entered into a definitive agreement to acquire Biotronic NeuroNetwork, a company which provides intraoperative neurophysiological monitoring services.
NuVasive will acquire the company for US$98 million.
According to a press release, NuVasive hopes that this acquisition will enhance its portfolio...

Age-related injuries such as femoral neck fractures often result in care dependency. However, it does not necessarily have to be that way, suggested Tim Pohlemann (Saarland University Medical Center, Hamburg, Germany) at the 17th EFORT Annual Congress (1–3 June,...

Zimmer Biomet and LDR have announced a definitive agreement under which Zimmer Biomet will acquire all of the outstanding shares of LDR.
The purchase price has been agreed at US$37.00 per share in cash, which implies a transaction value of...

Vertera Spine has announced the first wave of implantations with the Cohere cervical interbody fusion system. Cohere features the company’s patented porous PEEK (polyether ether ketone) Scoria biomaterial technology.
According to a press release, Cohere is the first device in...

The US Food and Drug Administration (FDA) has finalised its efforts to streamline the “compassionate use” process, used by physicians to access investigational drugs and biologics for patients with limited treatment options.
A statement from Robert Califf, the deputy...

A new bill introduced to the US Senate by Senator Dan Coats seeks to address the gap between the US Food and Drug Administration (FDA)’s priority review process for breakthrough medical devices, and the Centers for Medical and Medicare...

The entire platform of interbody products from Tyber Medical has been accepted into the Australian Registry of Therapeutic Goods.
According to a Tyber Medical press release, Therapeutic Goods Administration approval—along with product reimbursement codes—ensures straightforward access to products in the...

Eden Spine’s Sphynx plating system has been granted CE mark approval.
Made of titanium, the low profile Sphynx is intended to be implanted via the anterolateral approach for the treatment of thoracolumbar instabilities. Indications include spinal fractures, vertebral tumours, secondary...

The US Food and Drug Administration has granted 510(k) clearance to Additive Orthopaedics for its 3D-printed titanium digital fusion implant.
"Additive manufacturing allows us to develop complex geometries at reasonable manufacturing costs not possible before now with traditional manufacturing," says Greg...

Whilst intraoperative fluoroscopic navigation may offer a number of benefits to spinal surgery, uptake in the field is still relatively low. Jeff McConnell talks to Spinal News International about the limits of this technology.
What can intraoperative fluoroscopic navigation enable physicians to...

Life Spine has reported that the first cases have been successfully performed with the company’s Plateau-Ti spacer system.
Plateau-Ti is a titanium interbody system using Osseo-Loc, a surface treatment with 500-600 microns of porosity designed to help create an environment...

Implanet has nominated Mary E Shaughnessy as its new Board director.
Drawing on 20 years of experience working for Partners Healthcare System in Boston, Shaughnessy’s specific expertise lie in the healthcare finance and reimbursement sector. She was senior vice president...

Pinnacle Spine has launched its InFill anterior lumbar interbody fusion (ALIF) interbody device. The device is designed to maximise wall thickness and graft chamber volume, ensuring optimal contact with the vertebral endplates by both the interbody device and bone...

K2M has received 510(k) clearances from the US Food and Drug Administration (FDA) to market its Cascadia cervical and the Cascadia AN lordotic oblique interbody systems featuring Lamellar 3D titanium technology. This is intended to allow for bony integration...

The Netherlands presidency of the European Council and representatives of the European Parliament have reached a political agreement on two draft regulations for medical devices. The new regulations are aimed at ensuring that medical devices and in vitro diagnostic...

Ortho Kinematics has received Health Canada authorisation for its Vertebral Motion Analysis “VMA” product. The VMA is now licensed for sale in Canada, expanding the VMA’s current list of markets, which include the USA and Europe.
The VMA is a...

The first InterLink product is a pedicle fixation system.
The system is made in the USA and includes of 22 polyaxial pedicle screws, 19 spinal rods, cross-connectors, and set screws, and can be used for single or multiple level...

Two presentations at the annual conference of the International Society for the Advancement of Spinal Society (6–8 April; Las Vegas, USA) have revealed potential benefits for cervical disc arthroplasty over anterior cervical discectomy and fusion (ACDF). Both using prospective,...

Rates of low back pain in the developing world have surpassed those of the developed world, with its prevalence growing in urban populations. A cross-sectional population-based study of 22,952 participants residing in Tehran, Iran, published in Spine, has found...

Mainstay Medical International has received CE mark approval for ReActiv8, its proprietary implantable neurostimulation system designed to treat disabling chronic low back pain.
According to a press release, the CE mark approval is based on positive results from the ReActiv8-A...

NuVasive has added the AttraX putty to its US biologics range.
AttraX Putty is a next-generation, synthetic bone graft product indicated for use as an autograft extender in posterolateral spine surgery. The biotextured surface features of AttraX putty is designed...

The first surgical operation with the Rosa Spine (Medtech) in Spain has taken place. The procedure, which was performed at Hospital La Fe of Valencia, treated a patient with degenerative disc disease.
The operation was performed on a 47 year-old...

Medtronic has launched the Spine Essentials platform in the USA. This is a new platform of spinal implants and instruments designed to make the most common cervical spine fusion procedures more efficient and help hospital systems manage costs, while...

Boston Scientific Corporation has launched the Precision Montage MRI spinal cord stimulator system after receiving approval from the US Food and Drug Administration (FDA).
The Precision Montage System offers customised relief to patients with chronic pain while also enabling...

The European Spine Journal has published six-month results from iMIA (iFuse Implant System Minimally Invasive Arthrodesis). iMIA is a randomised controlled trial conducted in Europe to measure the safety and effectiveness of minimally invasive sacroiliac joint fusion using iFuse (SI-Bone) implants, compared to conservative management...

Orthofix International has received US Food and Drug Administration 510(k) clearance, and announced the US limited market launch of the Forza PTC (PEEK titanium composite) spacer system.
Designed and manufactured using a proprietary method, Forza PTC spacers combine PEEK and...

Research on K2M’s Ravine lateral access system is to be presented at the SpineWeek 2016 Annual Meeting (May 16-20, Marina Bay Sands, Singapore).
"The Ravine lateral access system allows for a lateral approach to lumbar fusion, and the dual flat...

The International Society for the Advancement of Spine Surgery (ISASS) has released the results of a surgical preauthorisation survey of its membership, conducted by Pierce Nunley, John Small, Kelly Frank and Marcus Stone. Nunley et al presented the results...

With the ultimate goal of fostering transparency and improving the health of patients, the Yale University Open Data Access (YODA) project has entered an agreement with SI-Bone that will enable researchers across the world to gain access to the...

NSpine is surveying female patients to investigate the effects of anterior spinal surgery with regards to scars, sexual function and relationships as part of a pilot study. The group is also looking at the prevalence of sexual dysfunction in...

The first surgeries using Safe Orthpaedics’ new SteriSpineCC range for cervical vertebrae surgeries have gone ahead successfully.
Designed for single use, the SteriSpineCC kit is designed for ease of use, with its sterile instrumentation pre-mounted on the implant, aiming to...

One hundred spinal surgeries have successfully been performed with MedTech’s Rosa Spine robotic-assistive device for minimally-invasive surgery of the spine.
Surgeries using Rosa Spine have been performed by:
- Michel Lefranc, a neurosurgeon at Amiens-Picardy University Hospital (France)
- Michael Winking at...

TranS1 has announced that its axial lumbar interbody fusion (AxiaLIF) procedure has been shown to provide estimated savings of US$3,500 compared to transforaminal lumber interbody fusion (TLIF), according to an economic analysis published in the Journal of Managed Care...

EOS imaging has sold a 10th EOS system to the Shriners Hospitals for Children Network in the United States, to be installed in Los Angeles. This is the 11th EOS system installed globally in the Shriners Network.
In 2011, the...

SpinalCyte has been issued US Patent number 9,320,776, "Methods And Compositions For Repair Of Cartilage Using An In Vivo Bioreactor."
The technology described in the patent involves a device which is a resorbable and biodegradable structure that can be permeable...

CoreLink has launched the Entasis sacroiliac joint fusion system in the USA.
The system is designed to deliver autograft in an innovative way, and promote compression across the joint.
Featuring circumferential helical graft windows, Entasis is designed to self-harvest bone graft...

Spineology has announced the full US market release of its Palisade pedicular fixation system.
The Palisade pedicular fixation system is designed to minimise surgical invasiveness and enhance efficiency. The integrated break-off screw extensions and quick start screw are designed to...

SpineGuard is to launch its new PediGuard Threaded device commercially during the 2016 SpineWeek meeting in Singapore. According to a company release, this launch follows successful clinical evaluations performed by seven surgical teams in Europe and Asia.
“This novel three-in-one...

The first US surgical operation using the Rosa Spine system (MedTech) has been performed at Miami Valley Hospital (Dayton, USA).
Miami Valley Hospital was the first US site to acquire Rosa Spine, following US Food and Drug Administration (FDA) clearance...

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the two-level thoraco-lumbar components of the Revolution spinal system from Intelligent Implant Systems.
Revolution is intended to simplify single and two-level thoraco-lumbar fusions by providing a sophisticated novel...

The patented AsTris 1.0 spine simulator (BioTras) has been launched at the 18th annual American Society of Interventional Pain Physicians (ASIPP) conference. The product is designed to help doctors get training experience without the need to practice on a...

Interspinous process fixation devices are increasingly being used as minimally invasive alternatives for the management of spinal stenosis and for pedicle screw constructs in patients undergoing decompression and fusion. Spinal News International reviews the use of the ZIP ULTRA™,...

For more than a decade, PEEK-OPTIMA Natural, the first medical-grade unfilled PEEK from Invibio Biomaterial Solutions, has been used in spinal fusion surgeries, predominantly in the form of loadbearing cages. Spinal News International explores the potential of Invibio’s PEEK-OPTIMA®...

Highlights: -Positive signs for gene therapy in slowing the course of disc degeneration
-No consensus among spinal surgeons on tests for predicting success of spinal fusion surgery for chronic low back pain -Is there a role for vertebral augmentation in...

Neurological injury, pseudoarthrosis and progressive deformity are just some of the risks associated with the surgical management of high grade spondylolisthesis in young patients. A presentation chronicling fourteen years of experience treating the condition with a progressive reduction technique...

Orthopaedic spine surgeon Gunnar BJ Andersson, has taken the position of chairman of the Board of Directors of International Advocates for Spine Patients (IASP), sister organisation and patient advocacy arm of the International Society for the Advancement of Spine...

One of the most exciting areas of technology for spine is probably 3D printing which allows for the creation of virtually anything that can be designed or imaged on a computer. Initially developed in 1984, and recently applied to...

Christopher Bono (Brigham and Women’s Hospital, Boston, USA) has been appointed as North American Spine Society (NASS) president for 2015-16. He talks to Spinal News International about his involvement in the society’s ongoing projects, collaborations with other societies, and...

SI-Bone’s iFuse has now been used in over 20,000 procedures worldwide by more than 1,100 surgeons since its initial launch in early 2009.
According to a company release, iFuse procedure growth has been driven most recently by the extensive body...

Mazor Robotics has installed a Renaissance guidance system at Mercy Hospital in Miami, USA.
Mercy Hospital is the sixth Hospital Corporation of America (HCA)-affiliated facility to purchase a Renaissance system, and the second hospital in Miami-Dade County to receive...

Spinal Elements has been granted its 50th US patent by the United States Patent and Trademark Office (USPTO).
Spinal Elements’ US patent portfolio encompasses a range of inventions in spinal fusion and motion preservation technologies. It includes interbody devices, pedicle...

RTI Surgical has launched of the Release Laminoplasty Fixation System. The system is designed to provide an efficient, streamlined surgical experience, allowing for central spinal cord decompression from C3 to T3 in laminoplasty procedures.
The system consists of plates and...

The Chinese Patent Office has granted a patent to Pinnacle Spine Group for its InFill fusion technology.
According to a press release, the Chinese Patent Office is in the process of issuing Chinese Patent Application No. 201180020517, titled “Intervertebral Implants...

NuVasive has launched five new surgical solutions at the 84th American Association of Neurological Surgeons (AANS) Annual Scientific Meeting, being held April 30 to May 4, 2016 in Chicago, USA.
The products include:
AttraX Putty biotextured bone graft, a synthetic...

Seven-year follow-up data for the two-level application of the Prestige LP cervical disc (Medtronic) has shown favourable clinical outcomes and patient satisfaction for the artificial disc over two-level anterior cervical discectomy and fusion (ACDF).
The data was presented at the...

The US Food and Drug Adminstration (FDA) has approved the UNiD cervical rod for spinal surgery, when secured by their PASS OCT posterior cervical stabilisation system.
Immediately following the FDA clearance, Medicrea expanded their personalised UNiD technology and services to...

Lattice Biologics is to launch three new products using its patent-pending matrix-assisted regeneration (MAR) platform; MarBrane and MarGraft and MarCell.
"With the advent of the cell viability biomarkers that Lattice Biologics is developing and implementing in their tissue recovery process,...

InVivo Therapeutics has announced that the sixth-implanted patient in the INSPIRE study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic American Spinal Injury Association Impairment Scale (AIS) A...

Genesys Spine’s Binary anterior cervical plating system has been awarded the Iron A’ Design Award in the category of Scientific Instruments, Medical Devices and Research Equipment Design by the grand jury panel of the A’ Design Award & Competition,...

SpinalCyte has been issued a Canadian patent for their technology, focused on regrowth of the spinal disc nucleus using human dermal fibroblasts.
The technology described in the patent involves incorporating a matrix constructed of a synthetic polymer, a natural hydrogel,...

Underlining injuries associated with low back pain are often enhanced by psychological and social stressors, write the authors of a perspective published online by the Medical Journal of Australia.
Leigh Atkinson, from Wesley Pain and Spine Centre in Brisbane, Australia,...

Titan Spine has appointed of Ragan E Cheney as vice president of the General Counsel. Cheney’s main responsibility will be to protect Titan Spine’s legal interests and, importantly, to ensure that the company’s intellectual property portfolio and proprietary scientific...

Wenzel Spine has announced the full commercial availability of the VariLift-LX system throughout the USA.
VariLift-LX represents the next generation of Wenzel Spine’s expandable stand-alone interbody fusion devices. The zero-profile VariLift-LX system is designed to provide a broader portfolio of...

Domagoj Coric, a neurological spinal surgeon from Charlotte, USA, has become the newest member of the International Society for the Advancement of Spine Surgery (ISASS) Board of Directors.
“I am excited and grateful for the opportunity to serve on the...

Psychological disorders, such as depression and anxiety, have been independently associated with higher all-cause 30-day readmission rates after elective spine surgery, in research presented at the 2016 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting.
Winning the Robert Florin Resident...

Abbott is set to acquire St Jude Medical, expanding its portfolio to cover cardiovascular markets such as atrial fibrillation, structural heart and heart failure as well as neuromodulation. The combined company will thus produce devices across cardiovascular, diabetes, vision...

The treatment of many common spinal conditions by procedures designed to preserve motion or by the more conventional fusion was the subject of a series of debates at the 30th Annual Meeting of the North American Spine Society (NASS;...

William Tally (Athens Orthopedic Clinic, Greece) has performed the first spinal surgery using a new stem cell technology aimed at offering a long term solution to the degeneration of the spine.
Using a product from Vivex Biomedical located in Marietta,...

People with scoliosis are now closer to a genetic explanation for their condition. According to a report, an overactive gene called ladybird homeobox 1 (LBX1) is the start of a genetic chain reaction that causes the spine to grow...

SpinalCyte has announced the final results of its phase two animal studies for transplantation of human dermal fibroblasts (HDFs) for intervertebral disc degeneration.
Previously reported was a significant improvement in disc height. This final report builds on those findings with optimal dosage,...

Ortho Kinematics (OKI) has received CE mark approval for its lead product, Vertebral Motion Analysis “VMA”.
Prior to securing CE mark approval, the VMA had regulatory clearance from the US Food and Drug Administration (FDA) to commercialise in the United...

Life Spine has announced that the first clinical cases of the Gruve anterior cervical plate system have been performed.
James J Lynch, founder of SpineNevada (Reno, USA), says, “The locking mechanisms allow the screws to hyper angulate to accommodate varying...

Amedica has agreed a partnership with Shandong Weigao Orthopedic Device Company, a subsidiary of Shandong Weigao Group Medical Polymer Company, a medical device company in China specialising in the research and development and the production and sale of spinal,...

Over 850 spine surgeons, scientists, researchers, and exhibitors from more than 40 countries attended the International Society for the Advancement of Spine Surgery (ISASS) 16th annual meeting (April 6-8, Las Vegas, USA). Over 530 abstracts were submitted spanning all aspects...

Two-year results from SIFI (Sacroiliac Joint Fusion with iFuse Implant System)—a prospective multicentre clinical trial of SI joint fusion—have been published in The International Journal of Spine Surgery.
The trial included 172 subjects at 26 US centres, and was authored...

An experienced orthopaedic surgeon was able to successfully and accurately place percutaneous sacroiliac screws into a number of cadavers using a new augmented reality (AR) navigation system during a pilot study published in International Orthopaedics. The study authors hope...

One of the largest studies ever performed addressing subchondral bone marrow lesions, or “Modic changes” of the spine visible on magnetic resonance imaging (MRI), has found a clear association between the lesions and disc degeneration, as well as both...

Inspired by Alexander Fleming, Marek Szpalski wanted to become a medical researcher. After becoming disillusioned with a life in the laboratory, he embarked on a career in orthopaedic surgery, specialising in spinal surgery. Upon achieving his medical degree in...

Recent literature has associated posterior-only approaches to the treatment of cervical spondylotic myelopathy with increased mortality. According to a paper presented at the 2016 meeting of the International Society for the Advancement of Spinal Surgery (ISASS: 6-8 April, Las...

SpineSource has launched the L-Varlock lumbar cage in the USA. According to a company release, the L-Varlock is the only expandable interbody that can adjust in situ from 0 to 24 degrees of lordotic angle, and up to 7mm...

Australian regulatory authorities have approved Safe Orthopaedics’ SteriSpine ranges, which are to be distributed in Australia and New Zealand, following a distribution agreement with SSJ Health.
Pierre Dumouchel, interim chief executive officer of Safe Orthopaedics, says, “This approval is a...

NuVasive a has launched the Integrated Global Alignment (iGA) platform in the UK at BritSpine (Nottingham, UK).
Paul Kosters, NuVasive’s vice president of Europe, Middle East and Africa, says, "We are pleased to participate at BritSpine 2016…we are eager to...

Interventional Spine has launched a new line of products, which were showcased at this year’s International Society for the Advancement of Spine Surgery (ISASS) Annual Meeting in Las Vegas, USA.
The new products include recent size additions to the Opticage...

Premia Spine has launched the ProMIS fixation system with its Advanced MIS screw placement at the 2016 International Society for the Advancement of Spine Surgery Meeting (ISASS; Las Vegas, USA).
Steven DeLuca, from the Orthopedic Institute of Pennsylvania (Pennsylvania, USA)...

Previously injured axons (red) can grow through a dense astrocyte scar (green) in the presence of molecules that stimulate growth (blue).
According to a new mouse study, astrocyte scars—long considered responsible for blocking neuronal regrowth across the level of spinal...

RTI Surgical has launched new deformity instrumentation for its Streamline TL spinal fixation system for complex adult deformities or curvatures. The instruments were designed with a focus on versatility, ease-of-use and surgeon comfort, according to a company release.
The Streamline...

Implanet has been granted US Food and Drug Administration 510k clearance and CE marking in Europe to market its new Jazz Lock implant.
Jazz Lock is the first of a range of band products designed for degenerative spine disorder surgery....

The first procedure using the FLXfit expandable cage from Expanding Orthopedics (EOI) has been performed by William D Smith at the University Medical Center in Las Vegas, USA.
Smith, director of Performance Improvement for the Western Regional Center for Brain...

Medtech has made its first US Rosa Spine sale to Miami Valley Hospital, Dayton, USA.
The hospital is a 970-bed medical facility, which received the Healthgrades “America’s 100 Best Hospitals’ Award” in 2016, and has received the Healthgrades “Distinguished Hospital...

Until now, the role of galectins and their docking sites in osteoarthritis was largely unknown. In a study recently published in the Journal of Immunology, MedUni Vienna researchers have managed to identify the function of galectin-1 for the first...

TranS1 has named Brandon Arthurs vice president of research and development. In this role, Arthurs, a certified professional engineer, will be responsible for leading collaborations with surgeons and entrepreneurs to bring new medical products to market. According to a...

The US Food and Drug Administration (FDA) has approved spineEOS, an online 3D planning software for spine surgery based on EOS stereo-radiographic 2D/3D imaging from EOS imaging. This follows CE marking, which was reported in March 2016.
The spineEOS online...

K2M has received 510(k) clearance from the US Food and Drug Administration (FDA) for expanded indications of its Mesa Mini and Denali Mini spinal systems.
The Mesa Mini and Denali Mini spinal systems function as adjuncts to fusion, providing stabilisation...

The newly patented AsTris 1.0, designed to help doctors practice for spinal injections, is to make its debut Dallas, USA, at the 2016 American Society of Interventional Pain Physicians (ASIPP) conference, April 14-16 at the Hyatt Regency.
For pain management...

The Spine Hospital of Louisiana at The NeuroMedical Center, Baton Rouge, USA, has become the first hospital in the USA to install the Ultimax-i FPD multipurpose system from Toshiba America Medical Systems.
This X-ray system is designed to provide a wide...

Stryker’s Spine division has acquired use of the SafeWire product portfolio, including the Y-Wire guidewire and Tiger Jamshidi Needle Family for use in minimally invasive spine surgery.
Acquired from SafeWire, the Y-wire features a patented feature that is designed to...

Medovex has entered into an international distribution agreement with Innosurge, a supplier of orthopaedic surgery equipment. The agreement covers the distribution of its DenerveXSystem throughout Scandinavia, including Denmark, Sweden, Norway and Finland.
Innosurge is expected to provide sales, marketing and...

According to a company release, the OrtoWell distractor instrument for spinal surgery from OrtoWay can now be used by surgeons in connection with spinal tumour removal or trauma.
Following tests on animals and cadavers, it was shown that the device...

X-Spine—a subsidiary of Xtant Medical—has been granted clearance from the US Food and Drug Administration for the Xspan laminoplasty fixation system.
The Xspan device is intended for use in the lower cervical and upper thoracic spine (C3-T3). "We are very...

Renovis Surgical technologies has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Tesera SC, a porous titanium cervical interbody fusion system.
Tesera SC features a three-screw design and a locking cover plate to prevent...

Bone Therapeutics has announced the 12-month efficacy results from the first cohort of seven patients treated with Preob in its phase IIA severe osteoporosis trial. These initial data demonstrate positive effects on pain and osteoporosis blood markers associated with...

Five-year clinical results have shown cervical total disc replacement to offer a superior alternative to anterior discectomy and fusion for treatment of two-level symptomatic degenerative disc disease. The data have been published by the Journal of Neurosurgery: Spine.
Based on...

Older Americans are increasingly active, and this lifestyle shift has contributed to the rise in average age of a person experiencing a spinal cord injury. The changing demographic calls for a better understanding of how aging impacts recovery and...

Sacroiliac joint fusion surgery has grown in popularity over the past five years. Whilst procedure rates are still relatively low, many physicians are convinced of the surgery’s benefit for the treatment of pain generated in the sacroiliac joint. With...

SpinalCyte has announced the preliminary results of its Phase II Animal Studies for Spinal Disc Height Improvement.
The study began in 2014, and is led by Howard An, the Morton International endowed chair professor of Orthopedic Surgery and director of...

A seventh patient has been enrolled into the INSPIRE study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic American Spinal Injury Association Impairment Scale (AIS) A Spinal Cord...

Writing in the March 28 issue of Nature Medicine, researchers at University of California, San Diego School of Medicine and Veterans Affairs San Diego Healthcare System (San Diego, USA) with colleagues in Japan and Wisconsin, USA, report that they have...

Stimwave has begun to market the StimQ peripheral nerve stimulator (PNS) system for the relief of severe intractable chronic pain of peripheral origin.
The system is designed to provide relief to peripheral nerves with an implantable device that can be...

The number of segments involved in lumbar and lumbosacral procedures has been shown to affect the incidence of sacroiliac joint pain, in a study published online in Spine, confirming the symptom as a potential cause of low back pain...

Amedica has announced its first fabrication of complex, three-dimensional structures by a 3D printing process called robotic deposition, or robocasting. The final products have been examined under scanning electron microscopy to confirm the integrity and validity of the 3D...

According to a study published in The Spine Journal, the Spine Adverse Events Severity (SAVES) system—a recording instrument created to comprehensively record the mobility and mortality associated with complex spinal surgery—can be generalised to non-Canadian populations of all ages....

The use of stem cells in spinal surgery was a focus of discussion at both the Brussels International Spine Symposium (BISS; 20-21 November, Brussels, Belgium), and the Annual Meeting of the North American Spine Society (NASS; 14-17 October, Chicago,...

Blue Cross Blue Shield (BCBS) of Michigan, USA, the largest commercial insurer in the state of Michigan, has issued a positive medical policy statement for minimally invasive sacroiliac joint fusion.
BCBS of Michigan becomes the first of the 36 BCBS...

EOS imaging has received approval from the China Food and Drug Administration (CFDA) to market the EOS system in China.
The EOS system can now be marketed in 51 countries.
The EOS system is in clinical use in several markets in...

The US Food and Drug Administration has announced a proposal to ban most powdered gloves in the USA. While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care...

The US Food and Drug Administration (FDA) has proposed a rule change with regard to posterior cervical screw systems.
The FDA wishes to classify these systems as class II, which reflects ‘special controls’. Premarket notification will still be required to...

SpineGuard has announced a national stocking distribution agreement with OrthoPediatrics for the exclusive commercialisation of its PediGuard probes in US paediatric institutions.
“We are delighted to partner with OrthoPediatrics for the distribution of our smart drilling devices. I have been...

Jeff Dunkel, Titan Spine vice president for Strategic Partnering, has been appointed to the Executive Operations Committee of the Medical Device Epidemiology Network Initiative (MDEpiNet).
The initiative is a collaborative program of the US Food and Drug Administration (FDA)’s Center...

Orthofix has appointed Michael E Paolucci to its Board of Directors and its Compensation Committee.
A human resource executive, Paolucci has more than 20 years of global experience working with boards of directors and C-level executives to improve organisational capabilities...

Amendia has launched its new corpectomy device, the Incorporate, commercially in the USA. The device is intended to provide surgeons with a safe and versatile vertebral body replacement option to replace a collapsed, damaged or unstable vertebral body.
The Incorporate...

Precision Spine has announced the launch of its Reform modular pedicle screw system and Reform HA-coated pedicle screw system.
The Reform system features a cobalt chrome tulip with a proximal tapered triple lead thread, which is designed to help increase...

Implanet has started a prospective and multicentre clinical study, designed to document the outcomes of the Jazz band in adult degenerative and adult deformity indications.
Implanet has partnered with TFS International, a professional contract research organisation, to help promote a...

A new study has shown that vibrating the spine may reveal more than magnetic resonance imaging when it comes to treating back pain. Teaming with the University of South Denmark (Denmark) to study the lumbar spine of twins, Greg...

BioTras has received a US patent for AsTris 1.0 (US Patent No. 9,275,556) medical training simulator that for training in interventional pain management. The patent was approved on March 1, 2016.
Dallas-based pain management doctors John East and Brandon Knutson...

Medicrea’s UNiD lab services have now been used in more than 500 surgeries worldwide. The services include a real-time support team to surgeons in the pre-operative planning of spinal procedures, order fulfillment for the company’s UNiD patient-specific spinal rod...

Rainbow Medical is to collaborate with Medos International Sarl, part of the DePuy Synthes Companies of Johnson & Johnson. The collaboration will be focused on the development of a novel therapy for treating degenerative disc disease.
This collaboration seeks to...

Nanovis has received a grant award from the National Institute on Aging, part of the US National Institutes of Health (NIH). To date, Nanovis’ spinal nanotechnology platform and soft tissue regeneration nanotechnology platform have received eight competitive, peer-reviewed grants...

Medtech has sold its first Rosa Spine robotic surgery system in the USA to Miami Valley Hospital, Dayton, USA.
Miami Valley Hospital is a 970-bed medical facility. It is a recipient of the Healthgrades “America’s 100 Best Hospitals’ Award in...

Together, the American Academy of Physical Medicine and Rehabilitation (AAPM&R) and the American Association of Neurological Surgeons (AANS) are creating a Spine Patient Registry, which will support the collection and submission of quality data specific to spine patients and...

Advances in medical imaging and implant manufacturing are making it possible to tailor an implant to the patient receiving it, according to a press release from Rush University Medical Center, Chicago, USA.
Matthew Colman has begun using patient-specific rods in...

Women reported neck pain due to cervical disc degeneration at 1.38 times the rate of men in a study of adult patients treated at Loyola Medicine’s Pain Management Center, Maywood, USA.
The study by Meda Raghavendra and Joseph Holtman, of...

The first implantation of the VariLift-LX system (Wenzel Spine) has taken place. The company is to begin a limited release of the system, following the successful procedure.
VariLift-LX is a next generation addition to the company’s range of expandable stand-alone...

NuVasive has received regulatory Shonin approval for its Reline posterior fixation technology in Japan. According to a company release, this approval will prepare the market for the launch of the company’s Integrated Global Alignment (iGA) platform.
Jason M Hannon, executive...

The Thomas Jefferson University Hospital, Philadelphia, USA, has been added to the list of clinical sites now participating in Invivo’s INSPIRE study.
Thomas Jefferson University Hospital, in affiliation with the Magee Rehabilitation Hospital, is designated as one of the nation’s...

The US Food and Drug Administration (FDA) has given 510(k) marketing clearance to Life Spine for the Prolift expandable interbody system.
The all-titanium Prolift system is designed to restore disc height, in-situ, for minimally invasive posterior lateral interbody fusion, transforaminal...

NuVasive is to acquire Mega Surgical, the only Brazilian distributor of NuVasive products. The acquisition, which has been definitively agreed, is expected to close during the first quarter of 2016. Terms of the agreement have not been disclosed.
Jason M...

According to a six-moth post-implant update from Invivo Therapeutics, the fifth patient to be enrolled in the INSPIRE study has achieved an improvement from AIS A to AIS B.
The INSPIRE (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold...

Xtant Medical has received CE mark for its Aranax and Irix-A spinal devices, both of were presented at the American Association of Orthopaedic Surgeons (AAOS) 2016 Annual Meeting in Orlando, USA.
The Aranax cervical plating system is distributed as a...

The University of Louisville is also the Data Management Center for the Christopher and Dana Reeve Foundation's North American Clinical Trials Network for the Treatment of Spinal Cord Injury; the largest research network for spinal cord injury in the USA.

Celling Biosciences have produced research indicating mesenchymal stem cells can be optimised and proliferate when using silicon nitride, compared to the current PEEK and titanium biomaterial standards.

Precision Spine has added a third building to its Pearl, Mississippi campus, expanding the total manufacturing facility footprint by 30% to just under 30,000 square feet of space and creating 25 new jobs.

The US Food and Drug Administration (FDA) has confirmed the appointment of Robert Califf as its 22nd commissioner, following a US Senate vote of 88 to 4 in his favour. This appointment follows his role as Deputy Commissioner of the FDA Office of Medical Products and Tobacco, a position he has held since January 2015.

Research has concluded that the increased rate of intervertebral lumbar disc (IVD) herniation is most likely caused by an increase in lumbar disc hydration due to the reduced spinal loads experienced in space.

The new reimbursement coding, effective immediately, was released in the Diagnosis-Related Group system in 2016 in Germany. This coding allows for hospitals and outpatient centres to receive reimbursement for the use of the DenerveX System for the treatment of facet joint syndrome in the spine.

Researchers compared the inter- and intra-rated agreement of magnetic resonance imaging findings, and discovered that even inter-rated agreement ranged substantially, even in an idealised study setting.

VariLift-LX is indicated to be implanted in a unilateral or bilateral capacity via a posterior or transforaminal lumbar interbody fusion interbody fusion approach, and may be used stand-alone, without supplemental fixation.

The guidelines recommend infliximab for use within its marketing authorisation, as a potential treatment in adults whose disease has not responded adequately to, or who cannot tolerate, non-steroidal anti-inflammatory drugs.

Joseph Ciacci, clinical professor of Surgery at the UC San Diego School of Medicine and chief of Neurosurgery at the Veteran Affairs San Diego Healthcare System, has been named principal investigator at the site.

Jonathan Lewin of North Shore Forest Hills Hospital in New York has become the first surgeon in New Jersey, USA to adopt the FLXfit articulated and lordotic expandable cage for the treatment of minimally invasive transforaminal lumbar interbody fusion surgery.

The first idiopathic scoliosis surgical procedure using the Jazz platform in Brazil has been successfully performed by Raphael Pratali and his team at the Hospital do Servidor Público Estadual in São Paulo, Brazil.

The update, which revised and combined three previous guidelines, suggests that doctors of chiropractic are well-suited to diagnose, treat, co-manage and manage the treatment of patients with low-back disorders.

McAdoo has more than 27 years of global marketing, sales management and business development experience in the medical device industry, including spine, general orthopaedics, trauma, cardiovascular and urology.

The aim of the report is to identify those recommendations from current guidelines of high methodological quality that may be relevant for the potential new disease management programme, "Chronic back pain".

K2M has been granted CE marking for the Rhine cervical disc system, which can now be sold and distributed within Europe. This device is a next-generation product for the treatment of degenerative disc disease.

The US Food and Drug Administration (FDA) have cleared the Altos (Centinel Spine) posterior cervical thoracic stabilisation system. The product is indicated for use in either the lateral masses of the cervical spine or the pedicles of the cervical-thoracic spine.

A team from the Feinstein Institute for Medical Research, Manhasset, USA, have discovered a new, personalised approach to diagnosing low back pain. Their research has been published in Arthritis Research and Therapy.

The technology described in the patent involves incorporating a three dimensional matrix to expose the fibroblasts to a mechanical strain using intermittent hydrostatic pressure and/or fluid shear stress.

Bioventus has announced the appointment of Bill Hawkins, retired chairman and chief executive officer of Medtronic and currently lead director of Immucor, as its new chairman of the company's board of managers.

The world's first spinal fusion surgery performed with the one-step-insertion of pedicle "smart-screws", guided by SpineGuard's Dynamic Surgical Guidance (DSG) technology has taken place in Paris, France.

The study will now be formally known as "The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury."

A teenager at Tufts University, Medford, USA has spent three years developing a titanium-alloy spinal implant for adolescents with scoliosis, which expands as the patient grows, according to a report in Qmed.

ApiFix has begun connecting the parents of children in Australia, Canada and the USA who have adolescent idiopathic scoliosis (AIS) with spine surgeons in Europe and Israel currently using the ApiFix system to treat AIS.

Though these emerging biological repair methods still face challenges as they advance to and through clinical testing in patients, they may be able to offer significant pain reduction and restore flexibility and motion of the spine.

Multilevel posterior cervical fusions can be safely stopped at C7, rather than the upper thoracic spine, without increasing the risk of complications or subsequent fusion extension at short- to mid-term follow-up.

Anne Mannion and Achim Elfering discuss their research, which evaluates the longitudinal validity of beliefs in predicting future pain in the shoulders, neck and back. They consider if cognitive behavioural interventions, education and exercise programmes could serve to reduce the impact of back pain in high-risk groups.

Revision surgery for adult spinal deformity has been shown to incur significantly lower surgical costs than primary surgery. In a study from Johns Hopkins, Baltimore, USA, which calculated cost-effectiveness in terms of quality-adjusted-life-years (QALYs), revision surgery was also shown to have a lower overall two-year cost and higher QALY gains, although these results were not significant.

A clinical trial featured in the November issue of Neurosurgery has shown that minimally invasive sacroiliac joint fusion using triangular titanium implants is highly effective in reducing pain and disability for patients with sacroiliac joint (SIJ) dysfunction.

According to a study in the Journal of the American Medicine Association (JAMA), patients with acute low back pain (LBP) achieved no greater pain relief of improvement in functional outcomes when treated with naproxen combined either a muscle relaxant or opioid, than with naproxen combined with a placebo.

It is suggested that restoration of spino-pelvic alignment in short lumbar fusions may reduce the risk of revision surgery for adjacent segment disease. Although prospective clinical data is currently lacking, this finding is supported by biomechanical data.

The device is an "ultra-thin" layer of commercially pure titanium, molecularly bonded to a PEEK-Optima implant. It is designed for use as an adjunct to fusion in patients with degenerative disc disease, and for use in anterior cervical discectomy procedures.

SpinalCyte has announced the issuance of Australian Patent No. 2013257540, "Methods and Compositions For Repair Of Cartilage Using An In Vivo Bioreactor." This adds to the 11 US and foreign patents issued and directly owned by the company.

This product " an all-in-one pedicle screw system " could enable surgeons to perform multiple spinal correction manoeuvres during spinal fusion surgery with a single implant type and fewer instruments than can traditional pedicle screw systems.

Rather than coating the fusion device, this surface treatment is grown directly from the bulk PEEK material of Vertera Spine's Cohere system. Solvay's Zeniva PEEK is made up of both the porous surface technology and the device on which it is grown.

Benvenue Medical has announced the US commercial launch of their Luna 3D Interbody Fusion System, which it claims provides this least invasive approach to spinal fusion for treatment of symptomatic degenerative disc disease

The US market launch of the Posterior Spine Truss System by 4WEB medical has been announced at the North American Spine Society annual meeting in Chicago. This system is a line of interbody fusion devices with applications across posterior spine approaches including PLIF, TLIF, and Oblique procedures.

According to a new study presented at the 30th Annual Meeting of the North American Spine Society, 87% of lumbar spine surgery patients had more optimistic expectations of surgical outcomes than their surgeons did.

Simplify Medical has announced that it has received Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) to initiate a two-level clinical trial comparing its Simplify Disc with anterior cervical discectomy and fusion (ACDF) as a control. This IDE approval grants Simplify the option of expanding its clinical operations.

Cavux, which is designed to speed bone fusion during the healing process, has been introduced by Providence Medical Technology. It is a surface technology that produces micro-textures on titanium surfaces, using micro- and nano-textures created across the implant surface area serve to enhance the fusion process.

According to a new study presented at the 30th Annual Meeting of the North American Spine Society (NASS; 14-16 October, Chicago, USA), spine surgeons should choose a patient's own bone material rather than donor bone for better results in posterior atlantoaxial fusion.

Many complications "likely have minimal or no impact on ultimate patient outcome," according to Justin Smith, professor of Neurosurgery at University of Virginia Medical Center, Charlottesville, USA, who presented the findings at EUROSPINE 2015.

Using more than two cages in adult spinal deformity patients produces significantly better correction, clinical outcomes and significantly fewer neurological complications, according to data shared at EUROSPINE 2015.

Robert Gunzburg followed in the footsteps of his father and grandfather in becoming a doctor. Breaking with the family tradition of rheumatology, Gunzburg decided to specialise in spinal medicine. He told Spinal News International about his path to and what he has learned from his journey so far.

Percutaneous osteosynthesis consists of inserting screws into bone structures through a skin incision of less than 10mm. It is now performed percutaneously by interventional radiologists due to the development of cannulated screws inserted coaxially over a guide pin, and due to the level of accuracy possible with CT- or flat panel-guidance, writes Frédéric Deschamps.

Vessel-X (Spirit Spine) is a device used to undertake "vesselplasty" procedures, designed to restore vertebral body height following a vertebral compression fracture using a non-stretchable PET (polyethylene terephthalate) container.

Supported by the advanced TruLIF technique, Atlas Spine says that its family of True Position XL implants ranging from 36-51mm in length exceeds current TLIF offerings and provides implants comparable to anterior lumbar interbody fusion/lateral footprints using a posterior approach.

The NuVasive Spine Foundation (NSF), a non-profit organisation founded and managed by the company, has reached a cumulative milestone of approximately US$18.4m contributed since the Foundation’s inception in 2009.

SpineGuard has announced the CE marking for its DSG (Dynamic Surgical Guidance) Threaded Drill and the first surgery, a thoracolumbar scoliosis correction, in Lille's Centre Hospitalier Universitaire by Assaker, Chopin and Allaoui.

Although cervical total disc replacement remains a safe and effective procedure with low rates of complication and high levels of patient satisfaction, in patients with adjacent segment degeneration, significant heterotopic ossification and resulting loss of prosthesis function was observed at 10 years' follow-up.

The new clearance now broadens Lotus' indications for the placement of screws in the cervical (C1-C7) spine, providing surgeons with more surgical treatment options for improved treatment of various posterior cervical and thoracic pathologies.

The Reform system represents the first modular system on the market to feature a cobalt chrome tulip with a proximal tapered triple lead thread, designed to help increase the bone/screw interface to enhance pull-out strength and allow for efficient screw delivery.

A new study published in Neurology has found that when asked to choose between treatments that reduced pain or those that would help them stand or walk, lumbar spinal stenosis patients overwhelmingly chose pain relief.

Forty-three per cent of cervical spine deformity patients experience early complications following surgery with 24.4% of patients experiencing major complications, according to a presentation at EUROSPINE 2015 (2-4 September, Copenhagen, Denmark).